Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic

• On Wednesday, Abbott received FDA emergency use clearance for a 15-minute antigen test, making it his first home coronavirus diagnosis and practically guiding him to gain agency approval.

• The BinaxNOW COVID-19 Ag Card Home Test, which requires a prescription, offers a telemedicine service to guide users through the sample collection process on their own and to help them read and understand their results. Abbott said the $ 25 cost of testing and service is “the lowest currently available for home testing,” but warned it should only be done “with the supervision of a supervisor. Telehealth.”

• Abbott’s EUA comes a day after the FDA approved an Ellume antigen test from Australia as the first COVID-19 diagnosis that can be purchased without a prescription and can be performed completely at home, without a prescription. Some public health experts wonder why prescriptions are needed for certain tests, which could limit their availability as coronavirus cases continue to rise in the United States.

With this week’s permission from Abbott and Ellume’s rapid antigen tests, there are currently three COVID-19 diagnoses that consumers can fully utilize at home. Last month, the FDA gave the green light to the first full-home coronavirus test from Lucia Health, California-based biotech in Emeryville.

None of the three home tests are widely available yet. Abbott expects to provide 30 million home tests in the first quarter of 2021 and 90 million in the second quarter. Illume plans to produce more than 3 million tests in January and deliver 20 million to the United States in the first half of 2021, while Lucia said her COVID-19 test kit will be available nationwide in early spring. 2021 through healthcare professionals.

Lucia’s molecular test, which costs about $ 50, provides results in 30 minutes or less with nasal swab samples they collected themselves. Priced at $ 25 for its 15-minute antigen test, Abbott easily beats Lucia on both counts. Most in this regard are somewhere in between with its $ 30 antigen test providing results in about 20 minutes.

The three home tests also differ in their respective clearances for some symptomatic and asymptomatic individuals. While Lucia’s kit is approved for people 14 years of age and older who are suspected by their doctor of being infected with the virus, Ellume’s diagnosis is acceptable for people with or without coronavirus symptoms and those with children up to 2 years.

Abbott’s BinaxNOW home test is approved for people aged 15 and over who are suspected of having an infection by their doctor within the first seven days of symptoms appearing, as well as nasal swab samples from adults aged 4 and over who are equally suspicious of COVID. 19 by your doctor within the first seven days of symptoms occurring.

The BinaxNOW COVID-19 Ag Card Test is a different product than the $ 5 BinaxNOW COVID-19 Ag Card Test, which was FDA approved in August. The previous EEA only allowed the use of rapid antigen diagnostics by medical personnel or trained operators in certain non-clinical settings working with a CLIA certificate.

The FDA in Abbott USA’s announcement on Wednesday stated that while antigen tests are “very specific for COVID-19”, they are not as sensitive as molecular polymerase chain reaction (PCR) tests.

“This means that there is a higher chance of false-negative results than many molecular tests. Positive antigen test results, while generally very accurate, can be falsely positive, especially in areas with fewer infections,” the agency said.

When compared to laboratory-based molecular PCR testing, Abbott showed that data collected at four US research sites showed that the BinaxNOW COVID-19 Ag card home test had a 91.7% positive agreement (sensitivity) and a 100% negative agreement (specificity) in humans was found for seven days or less after the onset of symptoms at all cycle thresholds (Ct) and 100% positive agreement (sensitivity) in humans seven days or less after the onset of symptoms with Ct- Numbers of 33 or less.

According to Illume, her home antigen test correctly identified 96% of positive and 100% negative samples in a multi-site clinical study in adults and children over 2 years of age. In people with no symptoms, the test correctly identified 91% of the positive and 96% of the negative samples.

According to Lucia, her COVID-19 home test is comparable to the PCR gold standard for detecting SARS-CoV-2 infections. The company claims its molecular diagnostics, using a method known as a loop-mediated amplification reaction (LAMP), accurately detected 94% of infections found using “one of the most reliable FDA-approved” PCR tests in a clinical trial 98% of healthy and uninfected people correctly identified.

Both the Abbott BinaxNOW COVID-19 Ag Card Home Test and Lucia Self-Test Kit are currently only licensed for prescription use. Illume’s Antigen Test features an over-the-counter coronavirus diagnosis that can be used entirely at home without a prescription.

However, Michael Mina, professor of epidemiology at Harvard T.H. Chan School of Public Health, wondered why the FDA is even asking for prescriptions for some coronavirus tests at this point in the pandemic.

“The FDA has now admitted that COVID tests do not require a prescription. The real question now is how they continue to maintain these tests and require prescriptions for some tests but not others. These are all COVID tests. There is no reason to have this dichotomy now, “Mina said at a press conference on Friday.

At the same time, Mina argues that providing the FDA’s first COVID-19 PCR test at home without a prescription is of little use.

Last week, the FDA approved the first over-the-counter test requiring a lab to process a self-collected sample. This nod went to lab giant LabCorp, which sells the PCR test through its consumer website Pixel, and potentially extends to retail channels.

“Now you can get a COVID test from LabCorp without a prescription without anyone telling you that you need it, but it will take some time. You should get this test. You should use it to return it next time and you will get a result three days later, for that. Which has already lost all of its airtime. It will never work for public health, “Mina said.